Ropivacaine After Sternotomy | NCT02449486

Studies
Ropivacaine After Sternotomy

NCT02449486

Sponsor

Kuopio University Hospital

Status

Completed

Last Update Posted

Apr 24, 2018Actual

Enrollment

90Actual

Phase

Phase 4

Conditions

Postoperative Pain

Interventions

Ropivacaine

Countries

Finland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2014Actual

Primary Completion Date

Dec 2017Actual

Completion Date

Dec 2017Actual

First Submitted Date

May 18, 2015

First Submission Date that Met QC Criteria

May 19, 2015

First Posted Date

May 20, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 23, 2018

Last Update Posted Date

Apr 24, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Continuous ropivacaine infusion to sternotomy wound after coronary artery bypass grafting (CABG) or heart valve surgery to diminish postoperative pain.

Detailed Description

A multiporous catheter will be introduced into sternotomy wound to CABG or heart valve surgery patients and continuous ropivacaine infusion 4 ml/h will be started immediately after surgery. Ropivacaine infusion will be administered during 48 postoperative hours. All patients receive patient controlled analgesia (PCA) oxycodone after extubation in the PACU. All patients receive a standardized anesthesia during surgery.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

90Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Ropivacaine	Active Comparator	Ropivacaine 4 ml/h (8 mg/h) continuous infusion for 48 hours	Drug: Ropivacaine
Placebo	Placebo Comparator	Saline infusion 4 ml/h for 48 hours	Drug: Ropivacaine

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Ropivacaine	Drug		Placebo Ropivacaine

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Postoperative oxycodone consumption	postoperative PCA administered oxycodone	48 postoperative hours

Secondary Outcomes

Measure	Description	Time Frame
Pain measured with Visual Analog Scale	pain measured with VAS at rest and on movement	48 postoperative hours

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Elective CABG or heart valve surgery patients

Exclusion Criteria:

Psychic disorders
Sleep apnea syndrome
Diabetes mellitus (insulin dependent)
Obesity, body mass index (BMI) ≥ 35
Cardiac insufficiency, ejection fraction (EF) ≤ 30

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Pasi K Lahtinen, MD, PhD	Kuopio University Hospital	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Kuopio University hospital		Kuopio		FI70029	Finland

IPD Sharing Statement Module

Plan to Share IPD

Description

Data will be published in a peer reviewed medical publication

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D010149	Pain, Postoperative

Ancestor Terms

ID	Term
D011183	Postoperative Complications
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D010146	Pain

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000077212	Ropivacaine

Ancestor Terms

ID	Term
D000813	Anilides
D000577	Amides
D009930	Organic Chemicals
D000814	Aniline Compounds

Browse Leaves

Not provided

Browse Branches

Not provided